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NCT04793217Completed

A Randomized Trial of ImpACT+, a Coping Intervention for HIV Infected Women With Sexual Trauma in South Africa

Project Someleze: A Randomized Trial of ImpACT+, a Coping Intervention to Improve Clinical and Mental Health Outcomes Among HIV-infected Women With Sexual Trauma in South Africa

Source: ClinicalTrials.gov · Last updated 28 Aug 2026

Brief summary (registry, in English)

ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. We propose a full-scale randomized controlled trial to examine the effect of ImpACT+ on clinical outcomes in the period after ART initiation and to understand mental health and behavioral mechanisms through which viral suppression can be achieved. ImpACT+ will target women who are initiating ART in order to take advantage of a window of opportunity in HIV care and maximize care engagement. The aims are to test the effectiveness of ImpACT+ and explore its potential for implementation.

Status (registry)
Completed
Study type
Interventional
Enrollment
350 (actual)
First submitted
9 Mar 2021
Start date
18 Feb 2021
Primary completion date
3 Jul 2025
Lead sponsor
Columbia University
Diseases
HIV
NCT number
NCT04793217

What you commit to

  • Study type: Interventional
  • Participants enrolled: 350
  • From 18 Feb 2021 to the primary completion date, 3 Jul 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • \- High suicide risk

Who the study is looking for

  • Women with HIV who receive care at either study clinic
  • \>2 weeks to \<4 months since ART initiation
  • History of sexual trauma
  • Meets criteria for traumatic stress
  • Xhosa speaking

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Cape Town
Coordinator of this site? Confirm its status
Cape TownSouth AfricaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.